把握回调后的机会，积极布局 2026 年 医药生物 证券研究报告/行业定期报告 2025 年 11 月 24 日 执业证书编号：S0740519040001 Email：zhujq@zts.com.cn | 上市公司数 | 498 | | --- | --- | | 行业总市值(亿元) | 70,594.11 | 消费多点开花》2025-11-17 2、《医保国谈落下帷幕；关注乳腺 癌创新疗法动向》2025-11-10 3、《改善趋势延续，积极把握底部 反转机会》2025-11-07 | 评级： | 增持（维持） | | | 重点公司基本状况 | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | 简称 | 股价 | | | EPS | | | | | PE | | | 评级 | | 分析师：祝嘉琦 | | | | （元） | 2023A | 2024A | 2025E | 2026E | 2027E | 2 ...

证券研究报告 创新药周报20251123： 首个APOC3 siRNA疗法获批上市用于治疗FCS 2025-11-23 证券分析师 刘浩 执业编号：S0360520120002 邮箱：liuhao@hcyjs.com 联系人 段江瑶 邮箱：duanjiangyao@hcyjs.com 联系人 吴昱爽 邮箱：wuyushuang@hcyjs.com 本报告由华创证券有限责任公司编制 卖的出价或询价。本报告所载信息均为个人观点，并不构成对所涉及证券的个人投资建议。 请仔细阅读PPT后部分的分析师声明及免责声明。 @2021 华创版权所有 第一部分 本周创新药重点关注 国内创新药回顾 02 全球新药速递 03 01 代谢疾病与核酸靶向疗法 证券研究报告 资料来源：Umidakhon Makhmudova, et al.，Advances in nucleic acid-targeted therapies for cardiovascular disease prevention，Eliot A. Brinton, et al.，Familial chylomicronemia syndrome and treat ...

有机构分析指出，目前，创新药指数已经自高点回调20%左右，部分创新药公司回调幅度达到 30%-50%，市场预期从八、九月份的过分乐观，切换至目前的偏悲观状态，而很多创新药公司的估值也 已经回归合理甚至低估的水平。站在当前时点，我们有理由对创新药板块重新乐观起来——中国创新药 企业正在重塑全球创新药研发生态体系，背靠强大的产业趋势，创新药行情虽有波折，但总会螺旋上 升。 把握创新药深度回调机遇，配置工具首选同类最大港股通创新药ETF（520880）及其场外联接基金 （025221），标的指数恒生港股通创新药精选指数具备三大独特优势： 1、纯粹，全面。不含CXO，纯正创新药！全面覆盖创新药研发类公司。 2、龙头占比大。前十大创新药龙头权重超71%，表征创新药硬核力量。 3、风险更可控。对流动性较差的成份股强制降权，有力管控尾部风险。 | | | 港股通创新药ETF (520880) 标的指数 | | | --- | --- | --- | --- | | | | 前十成份股权重高达71.51%,龙头优势显著 | | | 代码 | 简称 | 权重(%) | 总市值(亿港元) | | 6160.HK | 百济神州 | ...

11月18日，科创创新药板块冲高回落，截至10:16，科创创新药ETF汇添富（589120）早盘大幅震荡，振幅近2%，当前微涨0.11%，资金小跑进 场，科创创新药ETF汇添富（589120）昨日强势吸金786万元！ 科创创新药ETF汇添富（589120）标的指数成分股涨跌不一，百利天恒涨超2%，百济神州涨超1%，一度涨超3%，泽璟制药涨超1%，荣昌生物、 艾力斯微涨，君实生物、博瑞医药等回调。 特别是出海方面，国信证券表示，随着国产创新药的临床数据和临床进度在全球范围内的竞争力越来越强，创新药出海的趋势不断加强。关注创 新药在海外的临床进展以及数据读出。中国创新药产业已经体现出长期向好的发展趋势，并在近年集中体现在BD交易的爆发式增长。值得注意的 是，对于大部分国产创新药，对外授权通常只是全球开发的起点，合作伙伴在海外的开发进度，以及后续全球临床数据的读出可以进一步加强产 品在全球市场商业化的确定性。（来源于国信证券20251023《看好创新药长期逻辑，关注底部反转标的》） 【创新药进入收获期，戴维斯双击可期】 2025 年三季度，A 股医药生物板块472 家上市公司，共实现营业总收入6,004亿元，实现归 ...

高开涨近5%。 消息面上，11月17日，百济神州宣布III期HERIZON-GEA-01研究取得积极结果。该研究旨在评估在联合化疗的基础上，HER2靶向双特异性抗体泽尼达妥单 抗单药或联合PD-1抑制剂替雷利珠单抗作为HER2阳性局部晚期或转移性胃食管腺癌（GEA，包括胃癌、胃食管结合部腺癌和食道癌）一线治疗的有效性和 安全性。 中信建投此前指出，百济神州泽布替尼持续放量，上调全年业绩指引。考虑到公司BTK海外放量超预期，以及PD-1在欧盟、日本等其他国家上市放量，以 及BCL-2、BTK CDAC、CDK4等重磅管线持续兑现带来商业化进一步兑现，维持"买入"评级。 编辑/doris ...

中信建投（601066）此前指出，百济神州泽布替尼持续放量，上调全年业绩指引。考虑到公司BTK海外 放量超预期，以及PD-1在欧盟、日本等其他国家上市放量，以及BCL-2、BTK CDAC、CDK4等重磅管 线持续兑现带来商业化进一步兑现，维持"买入"评级。 消息面上，11月17日，百济神州宣布III期HERIZON-GEA-01研究取得积极结果。该研究旨在评估在联 合化疗的基础上，HER2靶向双特异性抗体泽尼达妥单抗单药或联合PD-1抑制剂替雷利珠单抗作为 HER2阳性局部晚期或转移性胃食管腺癌（GEA，包括胃癌、胃食管结合部腺癌和食道癌）一线治疗的 有效性和安全性。 百济神州(06160)高开逾3%，截至发稿，涨3.53%，报223.2港元，成交额1196.27万港元。 ...

中信建投此前指出，百济神州泽布替尼持续放量，上调全年业绩指引。考虑到公司BTK海外放量超预 期，以及PD-1在欧盟、日本等其他国家上市放量，以及BCL-2、BTK CDAC、CDK4等重磅管线持续兑 现带来商业化进一步兑现，维持"买入"评级。 智通财经APP获悉，百济神州(06160)高开逾3%，截至发稿，涨3.53%，报223.2港元，成交额1196.27万 港元。 消息面上，11月17日，百济神州宣布III期HERIZON-GEA-01研究取得积极结果。该研究旨在评估在联 合化疗的基础上，HER2靶向双特异性抗体泽尼达妥单抗单药或联合PD-1抑制剂替雷利珠单抗作为 HER2阳性局部晚期或转移性胃食管腺癌（GEA，包括胃癌、胃食管结合部腺癌和食道癌）一线治疗的 有效性和安全性。 ...

Investment Rating - The report assigns an "Overweight" rating to the pharmaceutical and biotechnology industry, indicating that the industry index is expected to outperform the CSI 300 index by 10% or more over the next six months [2][34]. Core Insights - The pharmaceutical and biotechnology sector saw an overall increase of 3.08% from August 11 to August 15, 2025, ranking 10th among 31 industries and outperforming the CSI 300 index by 0.71 percentage points. Year-to-date, the sector has risen by 25.02%, ranking 4th among the industries and outperforming the CSI 300 index by 18.22 percentage points [4][14]. - The current PE valuation for the pharmaceutical and biotechnology sector is 31.31 times, which is at the historical median level, with a valuation premium of 145% compared to the CSI 300 index [4][20]. - Key sub-sectors that performed well include medical services, chemical pharmaceuticals, and medical devices, with respective increases of 6.60%, 3.80%, and 2.22% [4][13]. Market Performance - The pharmaceutical and biotechnology sector's performance for the week of August 11-15, 2025, showed a 3.08% increase, ranking 10th among 31 industries, and outperforming the CSI 300 index by 0.71 percentage points. Year-to-date, the sector has increased by 25.02%, ranking 4th among industries and outperforming the CSI 300 index by 18.22 percentage points [4][14]. - The top three performing sub-sectors were medical services, chemical pharmaceuticals, and medical devices, with increases of 6.60%, 3.80%, and 2.22% respectively [4][13]. Industry News - On August 12, 2025, the National Medical Insurance Administration announced the preliminary review list of drugs for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Directory, with 534 drugs passing the basic medical insurance review and 121 passing the commercial insurance review [5][28]. - On August 15, 2025, the National Medical Insurance Administration issued a temporary management method for disease-based payment, aimed at reforming the payment method primarily based on disease categories [5][29]. - On August 15, 2025, Novo Nordisk announced that the supplemental new drug application for semaglutide (Wegovy) was approved by the FDA for treating metabolic dysfunction-associated fatty liver disease (MASH) in patients with mid-to-late stage liver fibrosis [5][30]. Investment Recommendations - The report suggests that the pharmaceutical and biotechnology sector continues to strengthen after a slight adjustment, outperforming the broader market index. It recommends focusing on investment opportunities in innovative drugs, CXO, medical devices, traditional Chinese medicine, chain pharmacies, and medical services [6][31]. - Recommended stocks include Betta Pharmaceuticals, Teva Pharmaceutical, Kaili Medical, Anjies, and Huaxia Eye Hospital, while stocks to watch include Kelun Pharmaceutical, Qianhong Pharmaceutical, Haier Biomedical, Kangtai Biological, and Baipusais [6][31].

Core Viewpoint - The company has demonstrated strong commercial performance and growth in its product portfolio, particularly with its leading BTK inhibitor, Baiyueze, which has achieved significant market share and revenue growth in various regions [3][6][9]. Group 1: Financial Performance - In Q2 2025, the company reported total revenue of $1.3 billion, a year-over-year increase of 42% [3][6]. - Baiyueze's global revenue reached $950 million, reflecting a 49% increase year-over-year, solidifying its position as the leading BTK inhibitor in the U.S. market [6][9]. - The gross margin improved from approximately 85% to 87.4%, driven by a favorable product mix and production cost efficiencies [6][9]. Group 2: Product Development and Pipeline - The company has submitted the first NDA for Sotokura for the treatment of relapsed/refractory CLL patients and plans to submit a global application for MCL indications later this year [4][5]. - The company is advancing over 20 Phase 3 trials and expects to achieve more than 10 concept validation data readouts by the end of 2026 [3][4]. - The company is focusing on expanding its product pipeline in various disease areas, including breast cancer and solid tumors, with a strategic emphasis on rapid clinical concept validation [5][12]. Group 3: Market Expansion and Regulatory Approvals - Baiyueze has been approved in 75 markets globally, with recent expansions in reimbursement coverage in five new markets [8][9]. - Baiyuean has been approved in 47 markets, with 20 new markets added for reimbursement, including Japan, Europe, and Australia [8][9]. - The company anticipates continued growth in revenue from diverse geographic markets, with the U.S. and China being the largest contributors [9][10]. Group 4: Future Guidance - The company updated its 2025 revenue guidance to a range of $5 billion to $5.3 billion, reflecting strong growth expectations for Baiyueze and ongoing market expansion [6][9]. - The company aims to achieve positive GAAP operating profit and expects to generate positive free cash flow for the year [6][9].

Core Viewpoint - BeiGene has reported significant financial growth in the first half of 2025, achieving profitability for the first time since its IPO, driven by strong product sales and improved operational efficiency [1][2]. Financial Performance - Total revenue for the first half of 2025 reached RMB 17.518 billion, a year-on-year increase of 46.0% [1]. - Operating profit was RMB 799 million, and net profit attributable to shareholders was RMB 450 million, marking a turnaround from losses in the previous year [1]. - Product revenue amounted to RMB 17.36 billion, reflecting a 45.8% increase year-on-year [2]. Key Products - The BTK inhibitor, Zebrutinib, generated global sales of RMB 12.527 billion in the first half of 2025, up 56.2% year-on-year, with U.S. sales reaching RMB 8.958 billion, a 51.7% increase [2]. - Zebrutinib led the BTK inhibitor market in the U.S. for two consecutive quarters, with Q2 2025 sales of USD 684 million, a 43% increase [2]. - The PD-1 inhibitor, Tislelizumab, achieved sales of RMB 2.643 billion in the first half of 2025, a 20.6% increase, driven by new indications and increased hospital access [3]. Guidance and Future Outlook - The company has raised its full-year revenue guidance for 2025 from RMB 35.2-38.1 billion to RMB 35.8-38.1 billion, with a gross margin forecast of 80-90% [4]. - The company anticipates over 20 milestone developments in its blood cancer and solid tumor pipelines over the next 18 months [1]. - BeiGene is expanding its pipeline with three proprietary products in blood cancer and diversifying its solid tumor treatment portfolio [4]. Clinical Trials and Approvals - The company plans to initiate Phase III clinical trials for the CDK4 inhibitor BGB-43395 in 2026 for breast cancer treatment [5]. - Collaborations for lung cancer treatments are progressing, with applications for market approval in China under priority review [5]. - The bispecific antibody, BGB-A317, has been approved for use in HER2-positive cholangiocarcinoma and is set for further trials in gastric cancer [5].